Save Time and Money with cGMP Manufacture: Short-Run, Small Window Drug Manufacture at the Clinical Research Unit (CRU)

A small biopharmaceutical client was developing a higher-dose version of an existing treatment to block symptoms of opioid withdrawal. Since the drug had been on the market for some time, no current testing data were available. When the FDA placed a clinical hold on the IND submission to request animal studies to address a toxicology question, the sponsor came to Labcorp. This client needed a high-quality, low-cost solution with fast turnaround along with special preparation and custom containers for long-term stability testing. A customized, short run at the Labcorp cGMP-compliant clinical pharmacy met the need.